NCT05250583终止2 期
Use of a Double Amniotic Membrane Inserted in a Ring of Umbilical Vessels with Wharton's Jelly, Tissues Treated by the AMTRIX Process, in the Treatment of Keratitis Resisting Healing Medical Treatment
TBF Genie Tissulaire1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2020年6月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Keratitis healing within 15 days after the beginning of the treatment
研究概览
简要总结
The purpose of this open, mono center trial is to assess the impact of the use of an amniotic membrane on the healing of a keratitis resistant to medical treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female; age between 18 and 65 years.
- •Patient with non-infectious keratitis resistant to medical treatment for more than 15 days or recurrent after healing treatment.
- •Patient with quantitative and qualitative score for inflammatory ocular signs >
- •Patient with Oxford grade >
- •Informed and consenting patient with a relative or friend available to instill eye drops if necessary.
- •Patient affiliated to a social security system or beneficiary of such a system.
排除标准
- •Patient with active infectious keratitis (bacterial, parasitic or viral).
- •Patient with allergy to Oxybuprocaine or Tetracaine eye drops, to ester type local anesthetics and to fluorescein.
- •Current contact lens wear, including scleral lenses.
- •NSAID eye drops and any drops containing preservatives.
- •Antibiotic, anti-viral, anti-parasitic eye drops.
- •Patient with identified causes for the keratitis for which discontinuation of medical treatment beneficial.
- •Ocular surgery in the 3 months preceding the inclusion in the study.
- •Monophtalmic patient.
- •Person deprived of liberty by a judicial or administrative decision.
- •Adult subjected to a legal protection measure or unable to express his/her consent.
研究组 & 干预措施
LV-Visio-AMTRIX
Experimental
Sutureless amniotic membrane supported by a biological ring.
干预措施: LV-Visio-AMTRIX (Biological)
结局指标
主要结局
Keratitis healing within 15 days after the beginning of the treatment
时间窗: 15 days
Keratitis observed under slit lamp using fluorescein instillation. Keratitis considered healed if epithelialization of more than 50% and/or Oxford \< grade 2
次要结局
- Change in eye dryness(15 days, 30 days, 45 days)
- Stabilisation or decrease of pain evaluated on visual analog scale(1 day, 3 days, 5 days, 7 days, 10 days, 15 days, 30 days, 45 days)
- Preservation of epithelialization(15 days, 30 days, 45 days)
- Stable or decreased score for inflammatory and clinical signs of the ocular surface(1 day, 3 days, 5 days, 7 days, 10 days, 15 days, 30 days, 45 days)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
2 期
Use of a Biological Lens of Amniotic Membrane (LV-Visio-AMTRIX) in the Treatment of Trophic UlcersPersistent Corneal Epithelial DefectCorneal UlcerNCT05172349TBF Genie Tissulaire
已完成
1 期
Clinic Trial in Phase 1 Using Amniotic Membrane for the Skin Replacement in Big WoundsWoundNCT01948934Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia6
终止
不适用
Human Amniotic Membrane On Venous Leg Ulcers In an Elderly PopulationVenous Leg UlcerNCT06544564BioLab Holdings30
进行中（未招募）
不适用
The Use of Amniotic Membrane or Internal Limiting Membrane for Large or Refractory Macular Holes: A Prospective StudyMacular HolesNCT04904679Hospital Oftalmologico de Sorocaba23
进行中（未招募）
不适用
Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound ManagementDiabetic Foot UlcerNCT06420245Legacy Medical Consultants240